The present invention relates, in general, to flexible containers. More specifically, the present invention relates to containers for containing cell culture media and other sensitive fluids.
Cell culture media is typically a solution of amino acids, electrolytes, and vitamins. Usually, the solution is supplemented with fetal bovine serum, which is believed to contain growth factors and other proteins that are essential to mammalian cell growth, without containing antibodies. Media is typically sold in either a liquid or powder form. If the media is sold in a powder form, it must be reconstituted prior to use.
Typically, liquid cell culture media is packaged in glass bottles, or containers, and stored at temperatures of approximately 2 to about 4.degree. C. Glass bottles are used to package the cell culture media because of their barrier properties. Because amino acids are readily oxidized an oxygen barrier is needed. Furthermore, a carbon dioxide barrier is needed because typically a bicarbonate buffer system is used in the media. Moreover, it is critical that the interior surface of the container is inert because of the sensitivities of the cells to toxic leachables.
Cell culture media powder has been packaged in foil pouches or polyethylene bottles having screw caps. However, due to the structure of the pouches and/or bottles upon reconstitution the media must be placed in glass bottles. One of the disadvantages of powder media is that reconstituting the media and maintaining asepsis is labor intensive.
A typical "life cycle" for a glass bottle for containing cell culture media is as follows. The bottles are typically received from a glass manufacturer in bulk and inventoried by the media manufacturer. When needed, the bottles are unpacked, washed, and sterilized. The sterile bottles are then placed in a fill room where they are filled and capped. The filled bottles are conveyed from the fill room and inspected and labelled. The labelled bottles are placed in quarantine during testing of the product. Once a lot is released, the bottles are typically shipped to customers in specially designed corrugated cardboard containers. Customers must then unpack the bottles and store them in a refrigeration unit until use. When the bottles are used, they are uncapped using aseptic techniques and the media is removed by pouring it into another vessel or by pipetting. The glass bottle must then be disposed.
As illustrated above, the process of utilizing glass bottles for containing cell culture media has some clear disadvantages. Of course, the storage of glass bottles utilizes a large amount of warehouse space. This is not only a concern prior to the filling of the bottles with media but even after the bottles are filled The packaging density of glass bottles increases the warehouse space required in quarantine and release product.
Furthermore, the glass bottles are not presterilized and nonpyrogenic, therefore, prior to use, the bottles must be washed and sterilized. Moreover, due to the nature of glass, there is a possibility that the bottles will break or be damaged during shipping and handling.
Additionally, the typical techniques of removing the media from the glass bottles are time consuming and have a risk of contamination. Still a further disadvantage in using glass bottles is that there is a problem of disposing of the container after it has been emptied. An additional disadvantage of using a glass bottle is the cost associated with the handling of and the pre-filling processing of the containers.
Accordingly, there is a need for an improved container for containing cell culture media.